Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 December 2000 to 15 January 2001 (Decisions taken pursuant to Article 14 of Directive 75/319/EEC or Article 22 of Directive 81/851/EEC)
Date: 2001-01-26
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation

C 26/8

EN

Official Journal of the European Communities

26.1.2001

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

28.12.2000 Halocur

Intervet International BV (NL)
Wim de K(cid:246)rverstraat 35
5831 AN Boxmeer
Netherlands

EU/2/99/013/001-002

2.1.2001

(cid:151) Suspension of a marketing authorisation (Article 40 of Regulation (EEC) No 2309/93)

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

20.12.2000

Econor

Novartis Animal Health Austria GmbH
Biochemiestra(cid:223)e 10
A-6250 Kundl

EU/2/98/010/001-024

22.12.2000

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal Products
7 Westferry Circus
Canary Wharf
London E14 4HB
United Kingdom.

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2000 to 15 January 2001

(Decisions taken pursuant to Article 14 of Directive 75/319/EEC (1) or Article 22 of Directive 81/851/EEC (2))

(2001/C 26/05)

(cid:151) Issuing of a national marketing authorisation

Date of the
decision

Name(s) of the medicinal
product

Holder(s) of the marketing authorisation

Member State concerned

Date of
notification

27.12.2000

KØtoprofŁne
Ethypharm LP

See Annex

See Annex

28.12.2000

(1) OJ L 147, 9.6.1975, p. 13; as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).
(2) OJ L 317, 6.11.1981, p. 1; as last amended by Directive 93/40/EEC (OJ L 214, 24.8.1993, p. 31).

26.1.2001

EN

Official Journal of the European Communities

C 26/9

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE
OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDERS, PACKAGING AND
PACKAGE SIZES IN THE MEMBER STATES

ANNEX

Member State

Marketing authorisation holder/
applicant

Trade name

Strengths

Pharmaceutical form

Route of
adminis-
tration

Packaging

Package size

Austria
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Belgium
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Denmark
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Finland
(concerned
Member State)

Merck Generics UK Ltd
12 Station Close, Potters Bar
Hertfordshire EN6 1TL
United Kingdom

France
(reference
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Greece
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Ireland
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Italy
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Luxembourg
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Netherlands
(concerned
Member State)

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Sweden
(concerned
Member State)

United
Kingdom
(concerned
Member State)

Scand Pharm, Generics AB
Box 23033 (Ynglingagatan
14, 5)
S-10435 Stockholm

Ethypharm SA
17/21, rue Saint-Matthieu
F-78550 Houdan

Ethypharm
Ketoprofen SR

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

KØtoprofŁne
Ethypharm LP

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

Ethypharm
Ketoprofen SR

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

Ketofen Retard 100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack
Polypropylene
container with poly-
ethylene closure

KØtoprofŁne
Ethypharm LP

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

Ethypharm
Ketoprofen SR

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

Ethypharm
Ketoprofen SR

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

Ethypharm
Ketoprofen SR

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

KØtoprofŁne
Ethypharm LP

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

Ethypharm
Ketoprofen SR

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

10, 30, 100
capsules
10, 30, 100
capsules

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

14, 15, 28,
30 capsules

Ketoprofen
Retard
Scand Pharm

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack
polypropylene
container with poly-
ethylene closure

100 capsules
30, 100
capsules

Arket XL

100 mg
200 mg

Prolonged-release
capsules, hard

Oral use

PVC/Alu blister pack
Polypropylene

14, 15, 28,
30 capsules